METHOTREXATE
- Product NDC
- 55150-511
- 11-digit product format
- 551500511
- Labeler code
- 55150
- Product ID
- 55150-511_adc6f7e8-b3a3-476a-9939-0c5cbda63dbd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METHOTREXATE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRATHECAL; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Eugia US LLC
- Application
- ANDA201529
- Marketing category
- ANDA
- Marketing start
- 2024-09-11
- Substance
- METHOTREXATE SODIUM
- Active strength
- 100 mg/4mL
- Pharmacologic classes
- Folate Analog Metabolic Inhibitor [EPC], Folic Acid Metabolism Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METHOTREXATE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METHOTREXATE SODIUM | 100 mg/4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3IG1E710ZN |
| Rxcui | 1655959, 1655960, 1655967, 1655968 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-511-01 | METHOTREXATE | 01 in 1 CARTON | INJECTION, SOLUTION | 01 | | 2 |
| 55150-511-01 | METHOTREXATE | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 4 | | 2 |
| 55150-511-10 | METHOTREXATE | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 2 |
| 55150-511-10 | METHOTREXATE | 4 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-511 | METHOTREXATE INJECTION, SOLUTION [EUGIA US LLC] | 1 | Current NDC, 4 package rows | 20250215_63bb6fbf-dd59-4edc-af8f-d0c397ca1262.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55150-511-01 | 55150051101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-511-01) / 4 mL in 1 VIAL, SINGLE-DOSE | 2024-09-11 | No | No | Current |
| 55150-511-10 | 55150051110 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-511-10) / 4 mL in 1 VIAL, SINGLE-DOSE | 2024-09-11 | No | No | Current |